SCI

Stifel Initiates Research Coverage of ONWARD® Medical with a Buy Rating and Target Price of EUR 12.00

Retrieved on: 
Tuesday, April 9, 2024
Buy, EUR, Target price, BCI, Target, Research, Euronext, ARC, Movement, SCI

EINDHOVEN, the Netherlands, April 09, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announced that Stifel, a US-based full-service investment bank, has initiated coverage of ONWARD Medical with a Buy rating and Target Price of EUR 12.00 per share.

Key Points: 
  • EINDHOVEN, the Netherlands, April 09, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announced that Stifel, a US-based full-service investment bank, has initiated coverage of ONWARD Medical with a Buy rating and Target Price of EUR 12.00 per share.
  • This is a premium of 140% to the closing price of EUR 5.00 on April 8, 2024.
  • The initiation report was published April 8, 2024.
  • Stifel joins four other banks whose analysts cover ONWARD Medical, all of which maintain Buy ratings and Target Prices at substantial premiums to the current share price.

LSU Researchers' Nootkatone Studies Could Lead to Prevention of Lyme Disease

Retrieved on: 
Tuesday, April 9, 2024
Ozone, SCI, Innovation, Lyme disease, Biting, Ant, DEET, Tick, Research, Notifiable disease, Nootkatone, Biology, Che, Military personnel, Leg, NSF, Mosquito net, World Health Organization, CDC, Malaria, WHO, Patent, Chemical engineering, Biol, Tree, West Nile virus, FDA, Defense, Deer, LSU, Vaccine

The LSU researchers propose decreasing the cost of the nootkatone synthesis, making any products made with the compound affordable to the general public.

Key Points: 
  • The LSU researchers propose decreasing the cost of the nootkatone synthesis, making any products made with the compound affordable to the general public.
  • “The family of compounds that make up nootkatone is already proven to be both safer and more effective than existing commercial repellents,” principal investigator Dooley said.
  • Years ago, Laine discovered the efficacy of nootkatone as an insect repellent while collaborating with retired LSU AgCenter Entomologist Gregg Henderson in Laine’s lab.
  • Mosquito nets could be covered with it, or they could have cloth ankle bands with nootkatone so ticks can’t crawl up your leg.

ONWARD® Medical Submits De Novo Application to FDA for its ARC-EX® System

Retrieved on: 
Tuesday, April 2, 2024
De novo, DPT, BCI, Arm, Paralysis, Evaluation, Doctor of Philosophy, Quality of life, Euronext, BDD, Annual report, Craig Hospital, Spinal cord, Safety, ARC, Food, Marketing, FDA, SCI, NCS, Movement, Hand, Medical device

EINDHOVEN, the Netherlands, April 02, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to improve or restore movement, function, and independence in people with spinal cord injury (SCI), today announces it has submitted its De Novo application to the US Food and Drug Administration (FDA) to allow marketing of its breakthrough ARC-EX System to restore function of the upper extremities after SCI.

Key Points: 
  • The submission marks an historic milestone for the Company in its mission to restore mobility and function for people with SCI.
  • Once cleared by the FDA, ARC-EX will be the first-ever spinal cord stimulation therapy to restore hand and arm function after SCI and the first commercial product for ONWARD Medical.
  • “We are delighted to be one step closer to bringing our breakthrough ARC-EX System to people living with SCI after submitting this De Novo application for regulatory clearance in the United States,” said ONWARD Medical CEO Dave Marver.
  • The ARC-EX System was previously awarded FDA Breakthrough Device Designation (BDD) for upper limb function, which provided prioritized FDA review, the opportunity to interact with FDA experts, and the potential for additional reimbursement.

Lifeward CEO Issues Open Letter to Shareholders on Progress to Finalize Exoskeleton Medicare Payment Rate

Retrieved on: 
Monday, April 1, 2024
HCPCS, Durable medical equipment, Disability, Freedom, Face, Robotics, DBA, Macs, Medicare, CMS, SCI, Rehabilitation

MARLBOROUGH, Mass. and YOKNEAM ILLIT, Israel, April 01, 2024 (GLOBE NEWSWIRE) -- ReWalk Robotics Ltd. (DBA Lifeward™), (Nasdaq: LFWD) (“Lifeward” or the “Company”), a global market leader delivering life-changing solutions to revolutionize what is possible in rehabilitation, recovery, and the pursuit of life’s passions in the face of physical limitation or disability, today issued an open letter from Larry Jasinski, Chief Executive Officer, to shareholders discussing the Company’s progress with the Centers for Medicare & Medicaid Services (“CMS”) to establish a payment rate for ReWalk Personal Exoskeletons. The full letter is published below:

Key Points: 
  • As a result of the deferral, the payment rate is not included in CMS’ April 2024 Durable Medical Equipment, Prosthetics, Orthotics and Supplies (“DMEPOS”) fee schedule of Medicare payment rates that are effective April 1.
  • Our active engagement with CMS is ongoing and we work to establish the payment rate as soon as possible.
  • Until a payment rate for exoskeletons is added to the DMEPOS schedule, the Medicare Administrative Contractors (“MACs”) still have authority to approve and pay claims on a case-by-case basis with discretion to set the payment rate.
  • Lifeward intends to submit an additional 60-75 additional Medicare claims by the end of 2024 to accelerate its momentum in expanding access for qualified Medicare beneficiaries.

ONWARD® Medical Publishes Closing of Accelerated Bookbuild Offering and Public Offering in France

Retrieved on: 
Monday, March 25, 2024
Offerings, Private, Brussels Stock Exchange, Euronext, DSM-IV codes, NOT, Euronext Amsterdam, Movement, SCI, Security (finance)

EINDHOVEN, the Netherlands, March 25, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD) (the “Company” or “ONWARD Medical”), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disorders, announces today the closing of its previously announced private placement with institutional investors, certain founders, certain members of management, and certain members of the Board of Directors (the “Private Placement”) and of its separate public offering via the PrimaryBid platform with retail investors in France (the “Public Offer” and together with the Private Placement the “Offerings”).  The gross proceeds from the Offerings amount to €20 million. 

Key Points: 
  • OTHER RESTRICTIONS ARE APPLICABLE.
  • PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.
  • As of today, the new shares issued pursuant to the Offerings are admitted to listing and trading on Euronext Brussels and Euronext Amsterdam.
  • This press release does not constitute, contain, or form part of an offering of securities in any jurisdiction.

In Preparation for Expected Human Clinical Trials, NurExone Signs Agreement for Large Scale Preclinical Testing for Its Spinal Cord Injury Therapy, ExoPTEN

Retrieved on: 
Friday, March 22, 2024
Drug discovery, Rat, NRX, PTEN, Patient, Contract research organization, IND, Regenerative medicine, Behavior, Spinal cord, Spinal cord injury, SCI, Pharmaceutical industry

This large-scale animal testing represents a significant step towards filing an Investigational New Drug (IND) application in the US for NurExone’s ExoPTEN therapy for spinal cord injury (SCI).

Key Points: 
  • This large-scale animal testing represents a significant step towards filing an Investigational New Drug (IND) application in the US for NurExone’s ExoPTEN therapy for spinal cord injury (SCI).
  • Under the terms of the agreement, Vivox will provide Contract Research Organization (CRO) services to NurExone, as a prerequisite to commencing Human Trials under the planned IND.
  • The testing will encompass mobility, behavior, motor and sensory recovery of rats following Spinal Cord Injury and treatment with ExoPTEN," said Dr. Lior Shaltiel, CEO of NurExone.
  • By collaborating with Vivox, NurExone aims to accelerate the development and regulatory path of ExoPTEN, to bring this potentially transformative treatment to patients in need.

ONWARD® Medical Publishes Prospectus for Listing of New Shares

Retrieved on: 
Thursday, March 21, 2024
EUR, Offerings, AFM, Euronext, Prospectus, DSM-IV codes, Market, NOT, Movement, SCI

EINDHOVEN, the Netherlands, March 21, 2024 (GLOBE NEWSWIRE) -- ONWARD Medical N.V. (Euronext: ONWD) (the “Company” or “ONWARD Medical”), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI) and movement disorders, announces today that it has published a prospectus for the admission to listing of 4,444,444 ordinary shares in the Company’s share capital, with a nominal value of EUR 0.12 each, issued through a private placement with institutional investors, certain founders and certain members of management, and certain members of the Board of Directors (the “Private Placement”) and in a separate public offering via the PrimaryBid platform with retail investors in France (the “Public Offer”), for which pricing and allocation have occurred prior to trading on March 21, 2024 (the “Offerings”). In connection with the listing of the shares placed in the Offerings, a listing prospectus was published today. The prospectus was approved by the Netherlands Authority for the Financial Markets (AFM) on March 21, 2024 and can be downloaded via ir.onwd.com/shareholder-information.

Key Points: 
  • PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.
  • In connection with the listing of the shares placed in the Offerings, a listing prospectus was published today.
  • The prospectus was approved by the Netherlands Authority for the Financial Markets (AFM) on March 21, 2024 and can be downloaded via ir.onwd.com/shareholder-information .
  • This press release does not constitute, contain, or form part of an offering of securities in any jurisdiction.

ONWARD® Medical Successfully Raises €20 Million in a Capital Increase by Way of an Accelerated Bookbuild Offering and by Way of a Public Offering in France

Retrieved on: 
Thursday, March 21, 2024
Offerings, Public, Private, Brussels Stock Exchange, KBC, Euronext, DSM-IV codes, CSO, Euronext Amsterdam, NOT, SCI, Movement, Hand, Security (finance)

PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.

Key Points: 
  • PLEASE SEE THE IMPORTANT NOTICE AT THE END OF THE PRESS RELEASE.
  • “We are delighted to announce the successful capital raise of €20 million, including a fully subscribed upsize option despite challenging market conditions,” said Dave Marver, CEO of ONWARD Medical.
  • Existing shareholders participated in the deal with an aggregate of 333,333 shares and 333,333 shares respectively allocated to INKEF Capital and EQT Life Sciences.
  • Following the Offerings, INKEF Capital and EQT Life Sciences will respectively hold 11.5% and 11.2% of the Company’s share capital.

ONWARD® Medical Launches Capital Increase by Way of an Accelerated Bookbuild Offering and of a Public Offering in France for an Indicative Amount of EUR 15 Million, with an Up to EUR 5 Million Upsize Option

Retrieved on: 
Wednesday, March 20, 2024
Brussels Stock Exchange, SCI, Public, Private, KBC, VWAP, ARC, Hand, Acceleration, Regulation, DSM-IV codes, CSO, Movement, EUR, Private placement, BCI, Offerings, Public offering, Equity carve-out, Euronext, Issue, Euronext Amsterdam, Security (finance)

The final number of New Shares placed and the issue price per New Share (the “Issue Price”) will be announced after pricing of the Offerings.

Key Points: 
  • The final number of New Shares placed and the issue price per New Share (the “Issue Price”) will be announced after pricing of the Offerings.
  • The New Shares will be issued from the Company’s authorized capital under exclusion of the existing shareholders’ pre-emptive rights.
  • “It is the Company’s intention to raise gross proceeds of indicatively EUR 15 million from the Offerings, with an up to EUR 5 million upsize option.
  • A separate announcement will be made shortly regarding the Public Offer in France via the PrimaryBid platform and its terms.

ONWARD® Medical Launches Capital Increase by Way of an Accelerated Bookbuild Offering and of a Public Offering in France for an Indicative Amount of EUR 15 Million, with an Up to EUR 5 Million Upsize Option

Retrieved on: 
Wednesday, March 20, 2024
Failure, Economy, Brussels Stock Exchange, Exercise, Patient, Risk, European, Intellectual property, Marketing, SCI, Annual, Public, Private, KBC, AFM, Prospectus, Royal Victorian Order, VWAP, ARC, Hand, Acceleration, Part, Research, Classification, Enrollment, Certification, DSM-IV codes, CSO, FDA, Movement, Engineering, EUR, Private placement, BCI, Offerings, Public offering, Market, Issue, Euronext Amsterdam, Probability, Security (finance)

The Issue Price will be determined by the accelerated book-building initiated with institutional investors.

Key Points: 
  • The Issue Price will be determined by the accelerated book-building initiated with institutional investors.
  • The Public Offering will not extent to retail investors located outside of France.
  • The New Shares will be issued from the Company’s authorized capital under exclusion of the existing shareholders’ pre-emptive rights.
  • It is the Company’s intention to raise gross proceeds of approximately €15.0 million from the Offerings, with an up to €5 million upsize option.